Zyban (bupropion hydrochloride) Sustained-Release Tablets

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009 and August 2011

August 2011

PRECAUTIONS

Drug Interactions

In a study in healthy volunteers, efavirenz 600 mg once daily for 2 weeks reduced the AUC and Cmax of bupropion by approximately 55% and 34%, respectively. The AUC of hydroxybupropion was unchanged, whereas Cmax of hydroxybupropion was increased by 50%.Addition of pharmacokinetic information from a study of healthy volunteers taking efavirenz and bupropion.

Drugs Metabolized by Cytochrome P450IID6 (CYP2D6)

Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion.

July 2009

BOXED WARNING (updated)

All patients being treated with Zyban should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking Zyban in the post-marketing experience. When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban.

Advise patients and caregivers that the patient should stop taking Zyban and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of
symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

WARNINGS

These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.

When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban

In many post-marketing cases, resolution of symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

PRECAUTIONS

Psychosis, Confusion, and Other Neuropsychiatric Phenomena

In clinical trials with ZYBAN conducted in nondepressed smokers, the incidence of neuropsychiatric side effects was generally comparable to placebo. However, in the post-marketing experience, patients taking ZYBAN to quit smoking have reported similar types of neuropsychiatric symptoms to those reported by patients in the clinical trials of bupropion for depression.

Furthermore, some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide when attempting to quit smoking while taking Zyban.

MEDICATION GUIDE

Changes throughout include text: "changes in behavior, hostility, agitation, depression"

When you try to quit smoking, with or without Zyban, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.

High blood pressure (hypertension): Some people get high blood pressure that can be
severe, while taking Zyban. The chance of high blood pressure may be higher if you also use
nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (see “Can
Zyban be used at the same time as nicotine patches?”).

Severe allergic reactions: Some people have severe allergic reactions to Zyban. Stop
taking Zyban and call your doctor right away if you get a rash, itching, hives, fever,
swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or
tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.

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